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临床试验/NCT07409571
NCT07409571招募中不适用

Impact of Topical Triamcinolone Acetonide on Palatal Wound Healing, Patient Morbidity, and Quality of Life After Free Gingival Graft Surgery: A Randomized Clinical Trial

Kahramanmaras Sutcu Imam University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2025年10月16日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
55
试验地点
1
主要终点
Oral Health-Related Quality of Life

研究概览

简要总结

This randomized controlled clinical trial aims to evaluate the effects of topical triamcinolone acetonide application on wound healing and patient-reported outcomes at the palatal donor site following free gingival graft (FGG) surgery. A total of 55 patients with mucogingival deficiencies requiring FGG will be randomly assigned to either a control group receiving a collagen membrane or a test group receiving topical triamcinolone acetonide at the donor site. All palatal donor areas will be protected with a periodontal dressing. Clinical assessments will be performed on postoperative days 3, 7, 14, and 30. Wound epithelialization will be evaluated using the hydrogen peroxide bubbling test, while wound healing and scar formation will be assessed using the Landry, Turnbull, and Howley index and the modified Manchester Scar Scale, respectively. Patient-centered outcomes, including postoperative pain, discomfort, analgesic consumption, and oral health-related quality of life, will be assessed using visual analog scales and the Oral Health Impact Profile-14 questionnaire. The findings of this study are expected to provide evidence regarding the potential benefits of topical corticosteroid use in reducing palatal donor site morbidity following FGG surgery.

详细描述

Free gingival graft (FGG) surgery is widely used in periodontal plastic surgery to increase the width of keratinized gingiva and to treat mucogingival defects around teeth and dental implants. The palatal mucosa is considered the preferred donor site for FGG procedures due to its favorable anatomical characteristics and adequate tissue thickness. However, harvesting a free gingival graft results in a secondary-intention wound at the palatal donor site, which is commonly associated with postoperative pain, discomfort, bleeding, and delayed wound healing, adversely affecting patient compliance and quality of life.

Various biomaterials and therapeutic approaches have been proposed to reduce palatal donor site morbidity and to promote wound healing following FGG surgery, including collagen-based materials, platelet concentrates, low-level laser therapy, ozone therapy, and topical agents. Corticosteroids are potent anti-inflammatory drugs that inhibit the arachidonic acid pathway, reduce capillary permeability, suppress fibroblast proliferation, and decrease the production of inflammatory mediators, thereby contributing to reduced postoperative inflammation and pain. Triamcinolone acetonide, a corticosteroid commonly used in oral medicine, has demonstrated beneficial effects in the management of oral ulcerative and inflammatory lesions. However, to the best of our knowledge, there is no clinical study evaluating the effects of topical triamcinolone acetonide application on palatal donor site wound healing following FGG surgery.

This randomized controlled clinical trial will include 55 systemically healthy patients presenting with insufficient attached gingiva and/or gingival recession, for whom FGG surgery is indicated. Participants will be randomly allocated into two groups. In the control group, a collagen hemostatic absorbable sponge will be applied to the palatal donor site following graft harvesting. In the test group, topical triamcinolone acetonide will be applied to the palatal donor site. In both groups, the donor area will be covered with sterile aluminum foil and a periodontal dressing to standardize wound protection.

All surgical procedures will be performed by a single experienced clinician to ensure procedural consistency. Postoperative evaluations will be conducted on days 3, 7, 14, and 30. Wound epithelialization will be assessed using the hydrogen peroxide (H₂O₂) bubbling test. Wound healing quality will be evaluated using the Landry, Turnbull, and Howley healing index, and scar formation will be assessed using the modified Manchester Scar Scale. Patient-reported outcomes, including postoperative pain, discomfort, bleeding, changes in dietary habits, and analgesic consumption, will be recorded using visual analog scales. Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.

The results of this study are expected to clarify the potential role of topical triamcinolone acetonide in enhancing wound healing and reducing patient morbidity at the palatal donor site following free gingival graft surgery, thereby contributing to evidence-based clinical decision-making in periodontal plastic surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 18 years and older
  • Patients presenting with insufficient attached gingiva and/or gingival recession requiring free gingival graft surgery
  • Systemically healthy individuals (ASA I)
  • Full-mouth plaque score (FMPS) < 15% and full-mouth bleeding score (FMBS) < 15% at the time of surgery
  • Ability and willingness to provide written informed consent and comply with study procedures

排除标准

  • Presence of systemic diseases that may affect wound healing (e.g., diabetes mellitus, immunological disorders)
  • Use of systemic corticosteroids, immunosuppressive drugs, or anti-inflammatory medications within the last 3 months
  • Current smokers or tobacco users
  • Pregnancy or lactation
  • History of periodontal surgery at the palatal donor site
  • Presence of active infection, ulceration, or pathological lesions at the palatal donor area
  • Known allergy or hypersensitivity to corticosteroids, collagen materials, or study-related medications

研究组 & 干预措施

Test Group

Experimental

Participants in this group will receive a free gum graft procedure. After the graft is harvested, topical triamcinolone acetonide will be applied to the palatal donor area, and a collagen membrane (Cytoplast™ RTMFOAM™, Osteogenics Biomedical Inc., Texas, USA) will be placed over it.

干预措施: triamcinolone acetonide (Drug)

结局指标

主要结局

Oral Health-Related Quality of Life

时间窗: Postoperative Days 7, 14, and 30

Oral health-related quality of life was evaluated using the Oral Health Impact Profile-14 questionnaire. The scale consists of 14 items scored on a 5-point Likert scale ranging from 0 (never) to 4 (very often). Total scores range from 0 to 56, with higher scores indicating poorer oral health-related quality of life.

Number of participants with complete wound epithelialization

时间窗: Postoperative Days 7, 14, and 30

Epithelialization of the palatal donor site will be evaluated using the hydrogen peroxide (H₂O₂) bubbling test. The presence of bubbling will be recorded as absence of epithelialization, whereas the absence of bubbling will indicate complete epithelialization.

Wound Healing at the Palatal Donor Site

时间窗: Postoperative Days 7, 14, and 30

Soft tissue healing was assessed using the Landry, Turnbull, and Howley Healing Index . The index is scored on a 5-point scale ranging from 1 to 5, where higher scores indicate better wound healing.

Scar Formation

时间窗: Postoperative Days 7, 14, and 30

Scar formation at the palatal donor site, including color match, contour, and tissue deformity, will be evaluated using the Modified Manchester Scar Scale, which is scored on a scale ranging from 0 to 4, where higher scores indicate poorer scar outcomes.

次要结局

  • Postoperative Pain and Discomfort(Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14)
  • Analgesic Consumption(Postoperative Days 1, 2, 3, 4, 5, 6, 7 and 14)

研究者

发起方
Kahramanmaras Sutcu Imam University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Bozkurt

Assistant Professor

Kahramanmaras Sutcu Imam University

研究点 (1)

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